Recalls / Class III
Class IIID-0801-2020
Product
methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only, Mfd by: HIKMA FARMACEUTICA (PORTUGAL), SA; Dist by: WEST-WARD, Eatontown, NJ 07724, NDC 0143-9850-01.
- Brand name
- Methylprednisolone Sodium Succinate
- Generic name
- Methylprednisolone Sodium Succinate
- Active ingredient
- Methylprednisolone Sodium Succinate
- Route
- Intramuscular, Intravenous
- NDCs
- 0143-9850, 0143-9851
- FDA application
- ANDA202691
- Affected lot / code info
- Lot #: 1901113.1, Exp JUL 2021
Why it was recalled
Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to reconstitute product with 16 mL rather than the correct volume of 8 mL of Bacteriostatic Water for Injection with Benzyl Alcohol.
Recalling firm
- Firm
- Hikma Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Esterbrook Ln, Cherry Hill, New Jersey 08003-4002
Distribution
- Quantity
- 4840 vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2020-01-14
- FDA classified
- 2020-01-23
- Posted by FDA
- 2020-01-29
- Terminated
- 2021-09-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0801-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.